Blood, Occult, Colorimetric, in Urine
Catalogue number R21526, listed by Remel, Inc., United States, under Blood, Occult, Colorimetric, In Urine. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (2), Jilin (1), Guangxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
Record
| Listed by | Remel, Inc., United States |
|---|---|
| FDA product code | JIO |
| Device type | Blood, Occult, Colorimetric, In Urine |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6550 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K913005 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| R21526 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 10 |
| Teco Diagnostics | Teco Diagnostics | 6 |
| Detector UA 5 | Immunostics, Inc. | 1 |
| Clinitek Advantus® Analyzer | Siemens Healthcare Diagnostics Inc | 1 |
| Urisys 2400 Cassette | Roche Diagnostics Gmbh | 1 |
| Urisys 2400 Calibration strip | Roche Diagnostics Gmbh | 1 |
| Aimstrip US-4 | Germaine Laboratories, Inc. | 1 |
| Urine Reagent Strips, 5-parameter | LW Scientific, Inc. | 1 |
| Labstix® Reagent Strips | Siemens Healthcare Diagnostics Inc | 1 |
| McKesson | Mckesson Medical-Surgical Inc. | 1 |
| Urine Chemistry Strips | Urit Medical Electronic Co., Ltd. | 1 |
| Mission U120 Smart Urine Analyzer | Acon Laboratories, Inc. | 1 |
Showing 12 of 17. All products under Blood, Occult, Colorimetric, In Urine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K913005 | 1991-09-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.